IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.

FDA device recall Z-1871-2014 · posted 2014-06-25 · Terminated

Recall details

Recalling firm

Intuitive Surgical, Inc.

Reason for recall

In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue

Action taken

Medical Device Recall notifications were sent to the 4 affected sites on June 11, 2014. Letters describe the problem and the potential health risk. The two model numbers of the endoscope are listed and the statement that ISI will perform a software upgrade to the da Vinci System and replace the endoscopes. Letters request that the following actions take place: - Ensure that all appropriate personnel are fully informed of the information provided in the notification letter. - Complete and return the acknowledgement form using instructions provided. - Retain a copy of The letter for your records. Intuitive representatives will schedule a site visit to provide the re-calibrated endoscope, update the software and ensure that it is properly integrated with the da Vinci Xi Surgical System. Questions or concerns may be directed to Intuitive Customer Service at 800-876-1310.

Root cause

Device Design

Status

Terminated

Product code

NAY

Quantity affected

19 units

Distribution

Distributed in the states of FL, TX, and NY.

Date initiated

2014-06-11

Date posted

2014-06-25

Date terminated

2014-07-02

Location

Sunnyvale, CA